Preoperative Presence of Gastric Content in Non-fasting P... | NCT03685435

Studies
Preoperative Presence of Gastric Content in Non-fasting Patients - an Ultrasound Study

NCT03685435

Sponsor

University Hospital, Akershus

Status

Completed

Last Update Posted

Nov 21, 2019Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Non-fasting Patients
Rapid Sequence Intubation
Anesthesia Intubation Complication

Interventions

Bedside ultrasound

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2019Actual

Primary Completion Date

Feb 17, 2019Actual

Completion Date

Feb 17, 2019Actual

First Submitted Date

Sep 25, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Sep 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2019

Last Update Posted Date

Nov 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Using bedside ultrasound, the investigators will examine gastric content in non-fasting patients assigned to rapid sequence intubation (RSI). The procedure will be done immediately before intubation. The percentage of non-fasting patients who actually have gastric content will be determined.

Identifying gastric content is critical because presence increases the risk of pulmonary aspiration during intubation.

Detailed Description

Quantitative gastric content will be registered by measuring the cross section area of antrum using bedside ultrasound. The area and the patients age will be applied to estimate gastric volume.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-fasting patients		We will examine non-fasting patients using bedside ultrasound. First we examine the gaster in a supine position. Then we repeat the procedure in a right lateral position.	Other: Bedside ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bedside ultrasound	Other	Checking for gastric content using bedside ultrasound	Non-fasting patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
High risk of aspiration	Detection of solids, or more than 1,5 mL/kg clear fluid in the gaster	Immediately before intubation
Low risk of aspiration	Detection of empty stomach, or less than 1,5 mL/kg clear fluid in the gaster	Immediately before intubation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults scheduled for surgery
Adults over 18 years old that are assigned to general anesthesia with rapid sequence intubation (RSI)

Exclusion Criteria:

Body mass index over 40
Pregnant women
Patients earlier underwent gastric surgery
Critically ill patients where spending time on ultrasound would cause a major disadvantage for the patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients that are assigned to rapid sequence intubation are considered non-fasting. Reasons for considering a patient non-fasting are among others: intake of food the last six hours, nausea, anxiety, preoperative intake of painkillers or reflux disease.

The ultrasound method we are using, are only valid for this specific population.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vegard Dahl, PhD	University Hospital, Akershus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akershus University Hospital		Lørenskog	Akershus	1478	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

We have not planned to share data with other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided